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EP/EMA Therapy (Etoposide Cisplatin/Etoposide Methotrexate Dactinomycin)

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EP/EMA Therapy (Etoposide Cisplatin/Etoposide Methotrexate Dactinomycin) NCCP Chemotherapy Regimen EP/EMA Therapy (Etoposide CISplatin/Etoposide Methotrexate DACTINomycin) INDICATIONS FOR USE: Regimen *Reimbursement INDICATION ICD10 Code Status Treatment of women with high-risk Gestational Trophoblastic Neoplasia D39 00264a Hospital (GTN) who have not responded or have relapsed from treatment with EMA/CO. GTN and hepatic metastases D39 00264b Hospital Women with GTN and hepatic metastases at presentation *If the reimbursement statusi is not defined, the indication has yet to be assessed through the formal HSE reimbursement process. TREATMENT: The starting dose of the drugs detailed below may be adjusted downward by the prescribing clinician, using their independent medical judgement, to consider each patients individual clinical circumstances. Treatment with etoposide and CISplatin (EP) alternates every 7 days with etoposide, methotrexate and DACTINomycin (EMA) and is administered continuously until normalization of hCG values or unacceptable toxicity develops. Patients with high-risk disease should have maintenance therapy for 3 cycles (6 weeks) after normalisation of hCG values. This may be extended to 4 cycles (8 weeks) in patients with poor prognostic features such as liver metastases with or without brain metastases. Published: 20/06/2016 NCCP Regimen: EP/EMA Therapy Version number: 2 Review: 07/02/2020 Tumour Group: Gynaecology ISMO Contributor: Prof Maccon Keane Page 1 of 5 NCCP Regimen Code: 00264 The information contained in this document is a statement of consensus of NCCP and ISMO or IHS professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is the responsibly of the prescribing clinician. and is subject to HSE’s terms of use available at http://www.hse.ie/eng/Disclaimer This information is valid only on the day of printing, for any updates please check www.hse.ie/NCCPchemoregimens NCCP Chemotherapy Regimen Admin. Day Drug Dose Route Diluent & Rate Cycle Order 1 1 Etoposide 150mg/m2 IV 1000 ml 0.9% NaCl over 60minsa See above for details 2 1 CISplatin 75mg/m2 IV 1000ml 0.9% NaCl over 2 hours b See above for details 1 8 DACTINomycin 0.5mg IV Bolus n/a See above for details 2 8 Etoposide 100mg/m2 IV 1000 ml 0.9% NaCl over 60mins See above for details 3 8 Methotrexate 300mg/m2 IV 1000ml 0.9% NaCl over 12 hours See above for details 4 8 Folinic Acid 15mg PO Every 12 hours for 4 (taken doses (to be started 24hrs See above for details day 9) after start of methotrexate) aHypotension following rapid IV administration has been reported. Longer infusion times may be required based on the patient’s tolerance b Pre and post hydration therapy required for CISplatin See local hospital policy recommendations. Suggested prehydration for CISplatin therapy: 1. Administer 10mmol magnesium sulphate (MgSO4) ((+/-KCl 20mmol/L if indicated) in 1000 mL sodium chloride 0.9% over 60 minutes. Administer CISplatin as described above Post hydration: Administer 1000 ml 0.9% NaCl over 60mins Mannitol 10% may be used to as per local policy to induce diuresis, although there is no conclusive evidence that this is required. The routine use of furosemide to increase urine flow is not recommended unless there is evidence of fluid overload (4,5). ELIGIBILTY: Indications as above EXCLUSIONS: Hypersensitivity to etoposide, CISplatin, methotrexate, DACTINomycin, or any of the excipients. PRESCRIPTIVE AUTHORITY: The treatment plan must be initiated by a Consultant Medical Oncologist. TESTS: Baseline tests: FBC, renal and liver profile human chorionic gonadotropin (hCG) Regular tests: FBC, renal and liver profile hCG Patient should have hCG levels monitored twice weekly during treatment. o After remission is achieved, serum hCG should be measured fortnightly until monitoring has shown one year of normal hCG levels. o Follow-up for at least 5 years may be considered for those at highest risk. Published: 20/06/2016 NCCP Regimen: EP/EMA Therapy Version number: 2 Review: 07/02/2020 Tumour Group: Gynaecology ISMO Contributor: Prof Maccon Keane Page 2 of 5 NCCP Regimen Code: 00264 The information contained in this document is a statement of consensus of NCCP and ISMO or IHS professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is the responsibly of the prescribing clinician. and is subject to HSE’s terms of use available at http://www.hse.ie/eng/Disclaimer This information is valid only on the day of printing, for any updates please check www.hse.ie/NCCPchemoregimens NCCP Chemotherapy Regimen Disease monitoring: Disease monitoring should be in line with the patient’s treatment plan and any other test/s as directed by the supervising Consultant. DOSE MODIFICATIONS: Any dose modification should be discussed with a Consultant. Renal and Hepatic Impairment: Table 1: Dose modifications in renal and hepatic impairment Drug Renal Impairment Hepatic Impairment Etoposide Cr Cl (ml/min) Dose Bilirubin AST Dose (micromol/L) >50 100% 26-51 or 60-180 50% 15-50 75% >51 or >180 Clinical decision <15 50% Subsequent doses should be based on clinical responses CISplatin Cr Cl (ml/min) Dose No dose reduction necessary >60 100% 45-59 75% <45 Consider CARBOplatin Methotrexate Cr Cl (ml/min) Dose Bilirubin AST Dose (micromol/L) (Units) >80 100% <50 and <180 100% 60 65% 51-85 or >180 75% 45 50% >85 CI <30 CI DACTINomycin Clinical decision – unlikely to require a Consider dose reduction in severe hepatic disease. reduction. Management of adverse events: Table 2: Dose Modification of methotrexate for Adverse Events Adverse reactions Recommended dose modification Mucositis Consider doubling folinic acid both in dose and duration before considering reduction in the dose of methotrexate. Third space fluids (ascites, pleural Hold methotrexate until recovery. effusions, very large ovarian cysts) Published: 20/06/2016 NCCP Regimen: EP/EMA Therapy Version number: 2 Review: 07/02/2020 Tumour Group: Gynaecology ISMO Contributor: Prof Maccon Keane Page 3 of 5 NCCP Regimen Code: 00264 The information contained in this document is a statement of consensus of NCCP and ISMO or IHS professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is the responsibly of the prescribing clinician. and is subject to HSE’s terms of use available at http://www.hse.ie/eng/Disclaimer This information is valid only on the day of printing, for any updates please check www.hse.ie/NCCPchemoregimens NCCP Chemotherapy Regimen SUPPORTIVE CARE: EMETOGENIC POTENTIAL: High (Refer to local policy). PREMEDICATIONS: Hydration prior and post CISplatin administration (Reference local policy or see recommendations above). OTHER SUPPORTIVE CARE: G-CSF may be used to mitigate the risk of haematological toxicities. ADVERSE EFFECTS / REGIMEN SPECIFIC COMPLICATIONS The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Neutropenia: Fever or other evidence of infection must be assessed promptly and treated appropriately. G-CSF will likely be needed to maintain white blood cell count. Hypersensitivity: Hypersensitivity reactions have been reported with etoposide and CISplatin. Monitor infusion of etoposide for the first 15 minutes for signs of hypotension. There is a high risk of hypersensitivity reactions with etoposide. Renal Toxicity: Nephrotoxicity is common with CISplatin. Encourage oral hydration. Avoid nephrotoxic drugs such as aminoglycoside antibiotics. Ototoxicity and sensory neural damage should be assessed by history prior to each cycle of CISplatin. Extravasation: DACTINomycin can cause pain and tissue necrosis if extravasated. DRUG INTERACTIONS: Current drug interaction databases should be consulted for more information. ATC CODE: Etoposide L01CB01 CISplatin L01XA01 Methotrexate L01BA01 DACTINomycin L01DA01 Folinic Acid V03AF03 REFERENCES: 1. Newlands ES, Mulholland PJ et al. Etoposide and Cisplatin/Etoposide, Methotrexate, and Actinomycin D (EMA) Chemotherapy for Patients With High-Risk Gestational Trophoblastic Tumors Refractory to EMA/Cyclophosphamide and Vincristine Chemotherapy and Patients Presenting With Metastatic Placental Site Trophoblastic Tumors J Clin Oncol 2000; 18,(4)854-859 2. May T, Goldstein DP et al. Current Chemotherapeutic Management of Patients with Gestational Trophoblastic Neoplasia Chemotherapy Research and Practice 2011;Article ID 806256, 3. NCCP Clinical Guidelines Diagnosis, staging and treatment of patients with gestational trophoblastic disease 2015. Available at http://www.hse.ie/eng/services/list/5/cancer/profinfo/guidelines/gtd/gtdguideline.pdf 4. Nephrotoxicity Associated with CISplatin EviQ ID: 184 v.3 https://www.eviq.org.au/clinical-resources/side-effect-and-toxicity-management/prophylaxis-and- prevention/184-nephrotoxicity-associated-with-CISplatin Published: 20/06/2016 NCCP Regimen: EP/EMA Therapy Version number:
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